Steam Sterilization Microbiology and Autoclave Performance Qualification

In this webinar, the steam sterilization mechanism will be described as it relates to bacterial cells and endospores. The process and key terminology are defined. Understanding these fundamentals is critical to develop a successful autoclave sterilization process.

Why Should You Attend:

Successful autoclave Performance Qualification starts with a fundamental understanding of steam sterilization microbiology.

Sterilization process parameters will be laid out as a basis for conducting autoclave performance qualification studies. Whether qualifying a new autoclave installation or continuing maintenance of existing equipment, there are specific expectations for steam sterilization that must be met.

Regulatory references requiring use of air removal verification tools, chemical indicators and biological indicators will be provided, along with definitions for sterility assurance level, accumulated lethality, temperature mapping and biological verification.

Common questions and hot topics in industry will be presented to demonstrate the practical application of understanding steam sterilization. These points exemplify how the knowledge allows for efficient troubleshooting of unexpected events and for improving processes in an autoclave.

Learning Objectives:

• Steam sterilization on a microbial level
• Autoclave Performance Qualification expectations
• Regulatory and GMP requirements for steam sterilization
• Process verification tools for use in an autoclave
• Common questions, problems and cGMPs

Areas Covered in the Webinar:

• Definitions.
• IQ/OQ/PQ Requirements for Autoclave Validation
• Autoclave Monitoring Tests
• Biological Indicators - How and When to Use
• Verification vs. Revalidation

Who Will Benefit:

• Quality Assurance Managers
• Supervisors
• Validation personnel
• Sterility Assurance personnel